K260224
- 510(k) number
- K260224
- Device name
- MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)
- Applicant
- ImpediMed Limited AU
- Product code
- DSB — Plethysmograph, Impedance
- Decision date
- 2026-08-17
- Date received
- 2026-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260224.pdf
Official FDA record: K260224
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.